Trial Information

- To determine if dose-dense docetaxel, cisplatin, and pegfilgrastim followed by
dose-intense erlotinib hydrochloride improves the time to progression in patients with
stage IIIB or IV non-small cell lung cancer compared to historical controls.

Secondary

- To assess response rate and median survival.

- To evaluate genetic polymorphisms as markers of response and survival, including
polymorphisms in XPD, XRCC1, XRCC3, and cyclin D1, in patients treated with this
regimen.

OUTLINE: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and
pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the
absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion
of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride
once daily in the absence of disease progression or unacceptable toxicity.

Blood is collected at baseline for pharmacogenetic studies. Samples are examined for genetic
polymorphisms.

After completion of study treatment, patients are followed every 3 months for 1 year and
every 6 months for 2 years.

Inclusion Criteria

Inclusion:

- Histologically or cytologically confirmed non-small cell carcinoma (NSCLC) including
any of the following subtypes:

- squamous carcinoma

- basaloid carcinoma

- adenocarcinoma

- bronchioloaveolar carcinoma

- adenosquamous carcinoma

- large cell carcinoma (not neuroendocrine)

- sarcomatoid carcinoma

- non-small cell carcinoma not otherwise specified

- Patients with previously completely resected disease must have histologically or
cytologically documentation or recurrence.

- Patients must be ineligible for Avastin or decline treatment with Avastin.

- No prior chemotherapy or treatment with an EGFR inhibitor is allowed. Brain
metastasis must be under control (patient neurologically stable).

- All Patients must have Measurable or Non-Measurable Disease

- Measurable disease is defined as at least one lesion that can be accurately
measured in at least one dimension. The longest diameter of measurable lesions
must be ≥20 mm with conventional techniques or ≥10 mm with spiral CT scan.

- Non-Measurable disease includes the following:

- Bone lesions

- Brain metastasis or leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions situated in a previously irradiated area

- ECOG Performance Status 0-1.

- Age ≥18 years.

- Required Initial Laboratory Data:

- Granulocytes ≥1,500/µl

- Platelets ≥100,000/µl

- Creatinine ≤ULN

- Bilirubin ≤1.5 mg/dl

- SGOT (AST) ≤1.5x ULN

- Alk. phos. ≤2.5x ULN

- Patients must provide verbal and written informed consent to participate in the
study.

Exclusion

- Patients who are pregnant or nursing because of significant risk to the fetus/infant.

- Patients with neuropathy ≥ grade 2.

- Patients with a psychiatric illness which would prevent the patient from giving
informed consent.

- Patients who are unable to take oral medications.

- Women with child-bearing potential or men who are sexual partners of women with
child-bearing potential who are not willing to practice adequate contraceptive
measures.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

W. Jeffrey Petty, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000601323

NCT ID:

NCT00723138

Start Date:

July 2008

Completion Date:

Related Keywords:

Lung Cancer

recurrent non-small cell lung cancer

stage IIIB non-small cell lung cancer

stage IV non-small cell lung cancer

adenocarcinoma of the lung

adenosquamous cell lung cancer

bronchioloaveolar cell lung cancer

large cell lung cancer

squamous cell lung cancer

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Name

Location

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